Status and phase
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About
This is a Phase I, Open-Label study evaluating the PK of S-1 components and their metabolites in patients with advanced solid tumors and varying degrees of hepatic function defined by the NCI classification for hepatic impairment. Patients will be stratified into 4 Cohorts- Normal, Mild, Moderate or Severe.
Six patients will be enrolled inot each cohort and receive S-1.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria:
A patient must meet all of the following inclusion criteria to be eligible for enrollment in this study:
Has histologically or cytologically proven advanced solid tumors for which no standard therapy exists.
Has provided written informed consent.
Is 18 years of age or older.
Is able to take medications orally.
Has Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to ≤ 2 (Appendix A, ECOG Performance Status).
Has adequate organ function as defined by the following criteria:
Is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Exclusion Criteria
Exclude a patient from this study if he/she does not fulfill the inclusion criteria, or if any of the following conditions are observed:
Has had treatment with any of the following within the specified time frame prior to study drug administration:
Has a serious illness or medical condition(s) including, but not limited to, the following:
Has known sensitivity to 5-FU. 5. Is a pregnant or lactating female. 6. Is a patient with reproductive potential who refuses to use an adequate means of contraception (including male patients).
Primary purpose
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Interventional model
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Data sourced from clinicaltrials.gov
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